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Recruiting Phase 1 NCT07052032

An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis

Trial Parameters

Condition Rheumatoid Arthritis
Sponsor Candid Therapeutics
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 47
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-06-16
Completion 2027-06-01
Interventions
CND261

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.

Eligibility Criteria

Inclusion Criteria: 1. 18 to 75 years old 2. Diagnosis of adult-onset RA 3. Class I-III RA 4. Moderately to severely active RA 5. Inadequate treatment response as defined in the protocol 6. Stable use of any concomitant therapies Exclusion Criteria: 1. Inadequate clinical laboratory parameters at Screening 2. Active infection 3. Receipt of or inability to discontinue any excluded therapies 4. Receipt of live vaccine within 4 weeks 5. Presence of any concomitant autoimmune disease 6. Active or known history of catastrophic anti-phospholipid syndrome 7. APS or thrombotic event not adequately controlled by anticoagulation therapy 8. History of progressive multifocal leukoencephalopathy 9. Central nervous system disease 10. Presence of 1 or more significant concurrent medical conditions 11. Have a diagnosis or history of malignant disease within 5 years 12. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair ability to receive planned treatment

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